Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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028
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Date of Entry 03/16/2012
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FR Recognition Number
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1-73
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Standard | |
ISO 10651-4 First edition 2002-03-01 Lung ventilators - Part 4: Particular requirements for operator powered resuscitators |
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Scope/AbstractISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent. ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators.
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
FDA recognition of ISO 10651-4 First edition 2002-03 [Rec# 1-73] will be superseded by recognition of ISO 10651-4 Second edition 2023-03 [Rec# 1-162]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-73] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 1-73] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.5915 |
Ventilator, Emergency, Manual (Resuscitator)
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Class 2
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BTM
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Relevant FDA Guidance and/or Supportive Publications*
1. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 2015.
2. Guidance for Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |